Effect of Superficial Cervical Plexus Block on Post Operative Nausea and Vomiting in Tympanomastoid Operations

Not Applicable

Completed

• Conditions: Postoperative Nausea and Vomiting
• Interventions: Procedure: ultrasound guided superficial cervical plexus block

• Registration Number: NCT05504551
• Lead Sponsor: Cairo University

Brief Summary

post operative nausea and vomiting are very common after tympanomastoid operations, in this study we are investigating the effect of superficial cervical plexus block on the incidence and severity of those post operative complications.

Detailed Description

various treatments and regimens have been tried to overcome the problem of postoperative nausea and vomiting after tympanomastoid surgery. superficial cervical plexus block seems so promising in this regards as it may reduce the incidence and severity of PONV through 3 mechanisms: primarily through blocking vagal afferents to the middle ear which mediate the vomiting reflex, and secondarily through decreasing pain which aggravates PONV, and finally through decreasing intra and post operative opioid consumption due to adequate analgesia which in turn avoids opioids side effects including PONV.

the study group will receive superficial cervical plexus block while the control will receive the same block while given placebo instead of (lidocain/bupivacaine mixture) incidence and severity of PONV will be recoded according to a scale to find the difference between both groups.

Study Timeline

• Study First Submitted: 2022-08-14
• Study First Submitted QC: 2022-08-16
• Study First Posted: 2022-08-17
• Study Start: 2022-08-31
• Primary Completion: 2023-01-01
• Study Completion: 2023-01-01
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-14
• Last Update Posted: 2023-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• Patients belonging to American Society of Anesthesiologists physical status I-II.
• operation time less than 4 hours.

Exclusion Criteria

• • American Society of Anesthesiology (ASA) physical status ≥ III.

  • Uncooperative or mentally retarded patients.
  • Known Allergy or hypersensitivity to lidocaine or bupivacaine.
  • Patients known to have gastritis or Gastro-oesophageal reflux disease (GERD).
  • History of PONV or motion sickness.
  • Operation duration (short less than 30 minutes or prolonged more than 240 min).
  • Patients with chronic renal disease (serum creatinine level ≥2.0mg/dl) or on renal replacement therapy (dialysis).
  • Patients with chronic cholecystitis (history of recurrent or persistent vomiting)
  • Skin inflammation and cellulitis.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group B	ultrasound guided superficial cervical plexus block	Superficial cervical plexus block (SCP) block is given using high frequency linear ultrasound probe connected to an ultrasound machine to visualize superficial cervical plexus (SCP) posterior to the midpoint of sterno cleido mastoid (SCM) muscle. Once SCP is identified, a combination of 5 ml bupivacaine (0.5%) and 5 ml lidocaine (2%) is injected after negative aspiration followed by injection of 1 ml to confirm the area, using a 22 gauge B-bevel Echogenic Needle.
group S	ultrasound guided superficial cervical plexus block	SCP block is given using high frequency linear ultrasound probe connected to an ultrasound machine to visualize SCP posterior to the midpoint of SCM muscle. Once SCP is identified, 10 ml of normal saline is injected after negative aspiration followed by injection of 1 ml to confirm the area, using a 22 gauge B-bevel Echogenic Needle.

Primary Outcome Measures

Name	Time	Method
PONV incidence over 24hour postoperative	24 hours	incidence of PONV according to PONV score from 0 to 3 where: 0= No nausea,no vomiting, 1= Nausea present, no vomiting, 2= Nausea present, vomiting present, 3= Vomiting\>2 episodes in 30 minutes, i.e., number of patients with PONV score of 0, number of patients with PONV score of 1, number of patients with PONV score of 2 and number of patients with PONV score of 3.

Secondary Outcome Measures

Name	Time	Method
To detect complications of regional ear block	24 hours	record complications include (hematoma-facial nerve palsy-oedema)
post operative pain score measured by visual analogue score (VAS) from 0 to 10, where 0= no pain and 10= unbearable pain.	up to 24 hours postoperative	post operative pain is assessed by visual analogue score from 0 to 10. patients are educated that 0= no pain, 5= distressing pain, 10= unbearable pain.
Intraoperative and postoperative complications	24 hours	Complications in the form of bleeding and facial nerve palsy
Need for postoperative analgesia	24 hours	first analgesic request
To monitor intraoperative hemodynamics	up to 4 hours	To monitor intraoperative heart rate and blood pressure
Side effects and toxicity of drugs	24 hours	record any side effects (local anaesthetic lidocaine-bupivacaine) e.g allergy, convulsions, hypotension.

Trial Locations

Locations (1)

Faculty Of Medicine- Cairo Univesity; 🇪🇬 Cairo, Egypt